Important Safety Information
INJECTAFER® (ferric carboxymaltose injection) is an infusion medication used to treat adults with iron deficiency anemia and/or non-dialysis-dependent chronic kidney disease. It’s an effective treatment for women with diminished iron levels due to recent childbirth or heavy menstruation. It is unknown whether INJECTAFER® would be an effective treatment in pediatric patients.
Do not receive INJECTAFER® if you are allergic to ferric carboxymaltose or any of the active or inactive ingredients in the medication. Prior to starting treatment, tell your doctor about your medical history — especially if you have high blood pressure, a history of iron overload or liver disease, or ever experienced an allergic reaction to infusion medications. In addition, let your healthcare professional know about all medications you’re currently taking — whether they’re prescription, over-the-counter, herbal supplements, and/or vitamins.
It is unknown whether INJECTAFER® would pass on to your baby through breast milk. Talk to your doctor if you’re breastfeeding or planning on doing so for alternatives for feeding your baby.
What is the most important information I should know about INJECTAFER®?
It’s possible to experience iron overload due to INJECTAFER® treatments. Such a condition could be harmful to your health and increase the risk of liver disease, diabetes mellitus, hypothyroidism, osteoarthritis, osteoporosis, heart attack, and/or heart failure. Tell your doctor immediately if you experience a metallic taste in your mouth, irregular heartbeat, your skin changes color to ash gray or green, abdominal pain, blood in the stool, hair loss, depression, infertility, chronic fatigue, or joint pain. Elevated iron levels also cause increased blood sugar, adrenal function problems, and/or early onset of neurodegenerative diseases.
INJECTAFER® may have an effect on laboratory results up to 24 hours after receiving an infusion treatment. Therefore, let all of your healthcare providers know of your infusion treatments prior to having any lab work done.
Side Effects of INJECTAFER®
As with any prescription medication, INJECTAFER® carries the risk of side effects. The most common ones include:
- Pain or bruising at the injection site
It’s also possible to experience an increase in liver enzymes and low levels of phosphorus in the blood. Some patients have also noted brown staining near the site of infection if the medication leaks out of the vein. In rare cases, it’s possible to experience more serious side effects, including:
- Breathing difficulties
- Rapid heartbeat
- Chest discomfort
- Serious allergic reactions
- High blood pressure
Tell your doctor immediately if you experience symptoms of an allergic reaction, such as itching, tingling, skin rash, muscle aches, and/or swelling of the mouth, face, lips, or tongue. Some reactions could be life-threatening, so you want your healthcare professional to be aware of any signs as soon as possible. Your doctor should monitor you for up to 30 minutes after each infusion treatment.
Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.
INJECTAFER® restores iron levels in two administrations of 750 mg — although dosage may vary according to the patient’s weight. Each therapy should be scheduled seven days apart. It may be necessary to conduct regular blood work to determine the length of treatment.
Please refer to the full prescribing information.